MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	U3575104
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual inspection: the sample was returned.Device packaging and labeling were not returned.The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 10mm x 40mm balloon.A complete compound rupture of the balloon was observed at the proximal cone; the distal portion of the balloon was fully detached from the device and not returned.The inner catheter was also detached 5.7cm from the glue joint; the distal marker band, the tip of the catheter, and the distal end of the balloon were not returned.The edges of the rupture and the inner catheter detachment were examined under microscopic magnification (10x) and were found jagged.The proximal marker band was still attached to the device.The outer catheter was found stretched at the glue joint, likely indicating retraction issues.Stretching of the outer catheter was also noted 0.2cm from the glue joint.Kinks were noted 29.5cm from the strain relief and 4.6cm from the glue joint.However, after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks.No kinks were reported by the user.No other anomalies were noted to the returned device.Functional/performance evaluation: no functional testing could be performed due to the condition in which the sample was returned (i.E.Balloon rupture/detachment).Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.The investigation was confirmed for a circumferential rupture and balloon detachment, as the device was examined and it was found that a complete circumferential rupture was noted at the proximal cone of the balloon, with the distal portion of the balloon detached and not returned.Based on the signs of stretching in the outer catheter, combined with the rupture and balloon detachment, the investigation was confirmed for retraction issues; however, the sheath and stent related retraction issues are inconclusive as the sheath and stent were not returned with the device.The balloon rupture (likely in the bare metal stent) lead to the retraction issues through the sheath, and the balloon detachment.Based on the condition of the returned sample (i.E.Stretching observed at the point of detachment), it is likely that excessive force contributed to the detachment.However, the definitive root cause for the balloon rupture could not be determined based upon the available information.It was unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter as a single unit.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.Potential adverse reactions: additional intervention.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during post-dilatation of a bare metal stent placed in the cephalic arch, the pta balloon allegedly ruptured (atm unknown) during the first inflation.It was further reported that a majority of the balloon detached and remained within the stent and the balloon catheter was difficult to retract through the stent and the sheath.Reportedly, a stent graft was deployed to appose the detached balloon segment against the stent and vessel wall.Another balloon catheter was exchanged over the guidewire and the procedure was completed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual inspection: the sample was returned.Device packaging and labeling were not returned.The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 10mm x 40mm balloon.A complete compound rupture of the balloon was observed at the proximal cone; the distal portion of the balloon was fully detached from the device and not returned.The inner catheter was also detached 5.7cm from the glue joint; the distal marker band, the tip of the catheter, and the distal end of the balloon were not returned.The edges of the rupture and the inner catheter detachment were examined under microscopic magnification (10x) and were found jagged.The proximal marker band was still attached to the device.The outer catheter was found stretched at the glue joint, likely indicating retraction issues.Stretching of the outer catheter was also noted 0.2cm from the glue joint.Kinks were noted 29.5cm from the strain relief and 4.6cm from the glue joint.However, after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks.No kinks were reported by the user.No other anomalies were noted to the returned device.Functional/performance evaluation: no functional testing could be performed due to the condition in which the sample was returned (i.E.Balloon rupture/detachment).Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.The investigation was confirmed for a circumferential rupture and balloon detachment, as the device was examined and it was found that a complete circumferential rupture was noted at the proximal cone of the balloon, with the distal portion of the balloon detached and not returned.Based on the signs of stretching in the outer catheter, combined with the rupture and balloon detachment, the investigation was confirmed for retraction issues; however, the sheath and stent related retraction issues are inconclusive as the sheath and stent were not returned with the device.The balloon rupture (likely in the bare metal stent) lead to the retraction issues through the sheath, and the balloon detachment.Based on the condition of the returned sample (i.E.Stretching observed at the point of detachment), it is likely that excessive force contributed to the detachment.However, the definitive root cause for the balloon rupture could not be determined based upon the available information.It was unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter as a single unit.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.Potential adverse reactions: additional intervention.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during post-dilatation of a bare metal stent placed in the cephalic arch, the pta balloon allegedly ruptured (atm unknown) during the first inflation.It was further reported that a majority of the balloon detached and remained within the stent and the balloon catheter was difficult to retract through the stent and the sheath.Reportedly, a stent graft was deployed to appose the detached balloon segment against the stent and vessel wall.Another balloon catheter was exchanged over the guidewire and the procedure was completed.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6546071
• Report Number: 2020394-2017-00411
• Device Sequence Number: 10796532
• Product Code: LIT
• UDI-Device Identifier: 00801741094583
• UDI-Public: (01)00801741094583(17)191231(10)CMBN0306
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: U3575104
• Device Catalogue Number: U3575104
• Device Lot Number: CMBN0306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 85