MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number U357554

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

It was reported that during an angioplasty procedure of a heavily calcified lesion in the sfa the pta balloon allegedly ruptured.After the rupture occurred the distal portion of the balloon circumferentially detached inside the patient.Reportedly, as the original guidewire was being removed from the patient, the distal portion of the balloon was attached to the guidewire and was able to be removed successfully.The health care provider was able to successfully deploy a stent at the lesion site to complete the procedure.

Manufacturer Narrative

A complete manufacturing review could not be conducted as the investigation is lot number unknown.Conclusion: the device was returned.A visual inspection found the device returned in two segments.A complete circumferential rupture was noted in the balloon.Additionally, the distal portion of the inner guidewire lumen and distal portion of the balloon was returned detached.Therefore, the investigation is confirmed for both a circumferential balloon rupture and catheter detachment.The investigation is also confirmed for dislodged marker bands, as both marker bands were dislodged and able to move freely along the guidewire lumen.Per the reported event details, the procedure was being conducted in a heavily calcified lesion in the superficial femoral artery.Therefore, it is possible that patient factors contributed to the identified rupture.The balloon rupture likely led to the catheter detachment during balloon removal.However, the definitive root cause for the rupture could not be determined based on the available information.Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.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.Use of the ultraverse 018 pta balloon 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 apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon.While maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the sheath and withdraw the deflated dilatation catheter over the wire through the introducer sheath.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.

Event Description

It was reported that during an angioplasty procedure of a heavily calcified lesion in the sfa the pta balloon allegedly ruptured.After the rupture occurred the distal portion of the balloon circumferentially detached inside the patient.Reportedly, as the original guidewire was being removed from the patient, the distal portion of the balloon was attached to the guidewire and was able to be removed successfully.The health care provider was able to successfully deploy a stent at the lesion site to complete the procedure.

• Brand Name: ULTRAVERSE 018 PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6638685
• MDR Text Key: 77542915
• Report Number: 2020394-2017-00613
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459(17)190930(10)CMAX0064
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: U357554
• Device Catalogue Number: U87556
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1