MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CATHETER

Model Number	U420038RX
Medical Device Problem Codes	Material Rupture (1546); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
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 upon opening the sealed outer box, blood was allegedly found on the outside of the inner packaging.The health care provider decided to use the pta balloon after removal from the inner packaging.It was further reported that during an angioplasty procedure of a vein graft in the left posterior tibial, the pta balloon allegedly ruptured at 8 am.There was no reported retraction issues.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.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 complaint reported to date for this lot number and failure mode.Investigation summary: the outer packaging box and inner packaging pouch were returned for evaluation; the catheter and packaging hoop were not returned.A visual inspection of the inner pouch found a dried brown substance on the exterior of the pouch (no substance was identified on the interior of the pouch, past the point of the seal).Additionally, a similar substance was found on the outer box label.However, because the device packaging pouch and box were returned opened, the investigation is inconclusive for the reported blood being present on the device packaging prior to opening.Additionally, the investigation is inconclusive for the reported rupture as the device was not returned for evaluation.Because the identified substance was found on the bottom edges of the inner pouch and outer box, it is possible that this was deposited on the packaging during removal of the device from the outer box.It is not unlikely that the substance is dried blood, given the environment in which the product is used/opened.However, the identity of the substance was unable to be confirmed.Per the manufacturing review, during manufacture of the device 100% visual inspection is conducted at qa inspection.Therefore, it is unlikely that this substance originated at the manufacturing site.The definitive root cause for the substance, or the reported rupture could not be determined based upon available information.Labeling review: the current ifu (instructions for use) states: warnings: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not use if sterile barrier is opened or damaged.Do not reuse, reprocess or resterilize.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 or catheter breakage, catheter kink, or balloon separation.Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.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.Do not exceed the rated burst pressure.To prevent over pressurization, use of a pressure monitoring device is recommended.Balloon rupture may occur if the rbp rating is exceeded.Potential adverse reactions: sepsis/infection handling & storage: store in a cool, dry, dark place.Do no store near radiation or ultra-violet light sources.
Event or Problem Description
It was reported that upon opening the sealed outer box, blood was allegedly found on the outside of the inner packaging.The health care provider decided to use the pta balloon after removal from the inner packaging.It was further reported that during an angioplasty procedure of a vein graft in the left posterior tibial, the pta balloon allegedly ruptured at 8atm.There was no reported retraction issues.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7202390
• Report Number: 2020394-2017-01921
• Device Sequence Number: 1173785
• Product Code: LIT
• UDI-Device Identifier: 00801741056871
• UDI-Public: (01)00801741056871
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: U420038RX
• Device Catalogue Number: U420038RX
• Device Lot Number: CMBT0162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 142