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

Catalog Number	U357586
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	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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 an angioplasty procedure the pta balloon allegedly ruptured.Following the rupture, the health care provider was retracting the balloon through the introducer sheath when the balloon allegedly detached inside of the patient.The health care provider decided to perform a secondary procedure to successfully remove the detached balloon segment.Patient status is unknown at this time.
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.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 8 mm x 60 mm balloon.The first segment contained the hubs, shaft, and the proximal base of the balloon.The device was examined under magnification (10x) and a complete circumferential rupture in the balloon was observed 3.8 cm from the glue joint.The inner lumen was found to be extensively stretched and kinked throughout, indicating retraction issues.A complete circumferential break in the inner lumen was noted 20.2 cm from the proximal glue joint.The second segment contains the distal tip and 4.2 cm of the distal portion of the balloon.The edges of the rupture and the inner catheter detachment were examined under microscopic magnification and were observed to be jagged.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 detachment).Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was examined under magnification, and a complete circumferential rupture was noted in the balloon with the distal portion of the balloon detached from the device.Based on the returned sample condition, the investigation was confirmed for a circumferential rupture and for balloon detachment.Additionally, the outer catheter and inner lumen were found to be stretched, confirming the investigation for retraction issues.The balloon rupture likely lead to the retraction issues and the balloon detachment.Based on the condition of the returned sample (i.E.Stretching observed on the outer catheter and inner lumen), 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 is 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.(b)(4).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 an angioplasty procedure the pta balloon allegedly ruptured.Following the rupture, the health care provider was retracting the balloon through the introducer sheath when the balloon allegedly detached inside of the patient.The health care provider decided to perform a secondary procedure to successfully remove the detached balloon segment.There was no reported impact or consequence to the patient.

• 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: 6542793
• Report Number: 2020394-2017-00409
• Device Sequence Number: 14276
• Product Code: LIT
• UDI-Device Identifier: 00801741093968
• UDI-Public: (01)00801741093968(17)190731(10)CMAV0182
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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: 07/31/2019
• Device Catalogue Number: U357586
• Device Lot Number: CMAV0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 06/20/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 93