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

Model Number	G52332
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products= terumo pinnacle sheath, boston scientific inflation.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
As reported, during an unknown procedure involving a patient of unknown age and gender, an advance 35 lp low profile balloon catheter ruptured below burst pressure.Another manufacturer's sheath was used during the procedure as well as another manufacturer's inflation device.The balloon ruptured upon initial inflation of the device and was removed by itself.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 information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Event or Problem Description
Additional information was received noting that the an omnipaque 300 contrast with a 50/50 contrast to heparin saline solution was used to inflate the device.The patient's anatomy presented with slight angulation, but no significant tortuosity or calcification.Reportedly, the target lesion was located below the knee popliteal site, to the trifurcation, and was approximately 80-90% stenosed.The device was never successfully inflated.Consequently, the balloon did not rupture as initially reported, but just did not inflate.According to the initial reporter, there was blood noted in the inflation device after the attempt to inflate.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Investigation ¿ evaluation: reviews of the complaint history, device history record, instructions for use (ifu), drawing, quality control procedures, and a visual inspection and functional test of the returned device were conducted during the investigation.The visual inspection of the returned device revealed no damage but did note biomatter present throughout the device.Functional testing was completed by inflating the balloon lumen with air when the catheter was submerged in water and a pin hole leak was identified in the proximal section of the balloon.The hole was believed to be the cause of the initially reported rupture and inability to inflate the balloon during the procedure.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 manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with the device, which notes that 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.
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 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: 9009805
• Report Number: 1820334-2019-02279
• Device Sequence Number: 2477508
• Product Code: DQY
• UDI-Device Identifier: 10827002523323
• UDI-Public: (01)10827002523323(17)220228(10)9557347
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2020

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: 02/28/2022
• Device Model Number: G52332
• Device Catalogue Number: PTA5-35-80-4-4.0
• Device Lot Number: 9557347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 01/06/2020
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 11/07/2019; 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1