MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G50333
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cadio solution innicoated device, 6fr terrumo destination 45cm.Occupation: non-healthcare professional.Pma/510(k) number = k170193.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) male with history of diabetes (type not specified), renal failure, and peripheral artery disease was undergoing an arteriogram procedure of an anterior tibial vessel, which was heavily calcified.The lesion was eighty per cent occluded.Prior to insertion of an advance 14 lp low profile balloon catheter, an atherectomy had been performed using another manufacturer's device.The complaint balloon was inflated to six atmospheres(atm) and ruptured.This was the initial inflation.There was no vessel angulation or tortuosity.Another manufacturer's six french sheath and an unknown inflation device and guide wire were also in use.The balloon had not been inflated inside a stent.No blood was noted in the inflation device.Although requested, it is not known if the balloon ruptured longitudinally or circumferentially.The balloon was removed over the guide wire without a sheath.A 3x16 balloon (cook) was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Reviews of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the correct device was returned for investigation.During the functional test, a pinhole rupture was found towards the middle of the balloon material.No other damage was noted on the device.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.While a review of the device history record showed nonconforming events which could contribute to this failure mode, it should be noted that all noted nonconformances were identified, scrapped, and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the drawings and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states the intended use outlines that it is for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.It is noted in bold that particular care should be taken in handling the balloon to prevent damage.The warning section states to not exceed the rated burst pressure.The complaint event occurred at 6 atm, which is below the nominal pressure: 8 atm, and the rated burst pressure: 16 atm.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8616129
• Report Number: 1820334-2019-01202
• Device Sequence Number: 11281343
• Product Code: LIT
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)220404(10)9642639
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 04/04/2022
• Device Model Number: G50333
• Device Catalogue Number: PTAX4-14-170-3-20
• Device Lot Number: 9642639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR