MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS PTA BALLOON DILIATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	AT120144
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454); Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 in the left iliac vein, after several inflations, the pta balloon allegedly ruptured at 20 atm and then allegedly got stuck in the stent that was present at the lesion site.It was further reported that the balloon was removed with force from the patient.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.Reportedly, the health care provider used another stent to pin the balloon fragment to the lesion site.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.Conclusion: the device was returned for evaluation.A visual inspection found the balloon fibers to be frayed and the pebax was peeled on the distal cone of the balloon.Therefore, the investigation is confirmed for frayed fibers and peeled pebax.An inflation attempt was made, and the balloon took on an asymmetrical shape, confirming the investigation for material deformation.The balloon was stripped of its fibers, and a longitudinal rupture was identified on the cone of the balloon, confirming the investigation for the reported rupture.However, the investigation is inconclusive for the reported insertion and retraction issues, as full functional testing for insertion or retraction issues could not be completed due to the device condition (e.G.Frayed material, rupture, etc.).Additionally, the investigation is inconclusive for the reported detached balloon fragments.Per the reported event details, the balloon allegedly ruptured at approximately 20atm.The rated burst pressure (rbp) for this balloon is 18atm.Therefore, the over-pressurization of the balloon resulted in the identified rupture.Additionally, the balloon was reported to have been stuck between two deployed stents, resulting in pulling the device out with force.It is likely that an interaction with the stent contributed to the frayed fibers, peeled pebax, and asymmetric inflation of the balloon.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.Precautions: if resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Use of the atlas pta dilatation catheter: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.While maintaining negative pressure and the position of the guidewire, 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 or Problem Description
It was reported that during an angioplasty procedure in the left iliac vein, after several inflations, the pta balloon allegedly ruptured at 20 atm and then allegedly got stuck in the stent that was present at the lesion site.It was further reported that the balloon was removed with force from the patient.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.Reportedly, the health care provider used another stent to pin the balloon fragment to the lesion site.There was no reported patient injury.

• Brand Name: ATLAS PTA BALLOON DILIATATION 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: 6976608
• Report Number: 2020394-2017-01429
• Device Sequence Number: 1352263
• Product Code: LIT
• UDI-Device Identifier: 00801741062636
• UDI-Public: (01)00801741062636
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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: 06/28/2020
• Device Model Number: AT120144
• Device Catalogue Number: AT120144
• Device Lot Number: GFBT4034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/10/2017
• 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: 47 YR
• Patient Weight: 80