MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52338
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during angioplasty of a stenosis in an av fistula in the arm, the advance 35 lp low profile balloon catheter ruptured.A 5fr cook radial access sheath was used to gain access and the balloon was introduced over a 0.035 cook roadrunner wire, reaching the desired location.The balloon was inflated once with a cook inflation device, using a 50/50 contrast to saline ratio, to "about 3" atmospheres before rupturing.The balloon was then removed over the wire.Reportedly, the target lesion was an av fistula in the patient's forearm that was 50% occluded, but did not contain calcification or tortuosity.It is unknown whether the balloon ruptured circumferentially or longitudinally, or if there was blood in the inflation device.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation/evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), quality control procedures, and a visual inspection as well as dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had biomatter present throughout the device.Further inspection identified a longitudinal tear in 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.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the drawing and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which contains labeling noting the device is indicated for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries; including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral; and obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The document also instructs that if balloon pressure is lost and/or the balloon ruptures, deflate the balloon and sheath as a unit.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.Measure are being taken to address this failure mode.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.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8920983
• Report Number: 1820334-2019-02073
• Device Sequence Number: 2397541
• Product Code: DQY
• UDI-Device Identifier: 10827002523385
• UDI-Public: (01)10827002523385(17)220326(10)9619783
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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 Model Number: G52338
• Device Catalogue Number: PTA5-35-80-5-4.0
• Device Lot Number: 9619783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR