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

Model Number	G52271
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
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, an advance 35 lp low profile balloon catheter ruptured during an angioplasty procedure of two stents (manufacturer unknown) due to in-stent restenosis.The lesion was located in the (b)(6) male's completely occluded left popliteal artery.Access was gained from the right groin.The rupture occurred when attempting to deflate the balloon inside the stent.The balloon was unable to completely enter the cook 6fr sheath for removal because it appeared to "ball up" at the end.The balloon did track over another manufacturer's 0.14 wire and was removed with the sheath (although not completely inside the sheath).The balloon did not separate.The procedure was completed with another sheath and another balloon.According to the initial reporter, another manufacturer's inflation device was used.The type and ratio of contrast was unknown.Only one inflation was performed; the pressure was over nominal pressure but not over burst pressure.The patient's vessel was neither tortuous nor calcified.There was no angulation present.It is not certain if the complaint device ruptured longitudinally or circumferentially.The patient did not experience any adverse effect nor require additional procedures as a result of this occurrence.
Additional Manufacturer Narrative
Investigation/evaluation: reviews of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that complaint balloon catheter was returned with the 6 french sheath on the shaft (b)(4) for investigation.Both devices had biological matter present throughout them.The balloon material appeared to have ruptured circumferentially, with a small longitudinal tear on a section.The inner shaft, below the balloon material, was elongated and thinned.There was no evidence of the product being manufactured out of specification.The elongated section of the shaft may have been caused when difficult in removing the balloon catheter was experienced.Additionally, a document based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the drawings, quality control procedures, and the overall design history file were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device.This documentation notes 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.It does not address those lesions which have previously had a stent placed and restenosis has occurred.Upon withdrawal, negative pressure is to be maintained.The document also instructs that if balloon pressure is lost and/or the balloon ruptures, deflate the balloon and sheath as a unit.Once the balloon ruptured, negative pressure was reported to have been maintained and initially the balloon was attempted to be removed through the sheath.When the customer was having difficulties with this, the sheath and balloon were removed together, as indicated in the ifu.The case description, compared to the product labeling, provided no evidence to support the customer misused the device in a way that led to the balloon rupture.When reviewing the product labeling, also provided with the device, it was noted that this balloon device was compatible with a 5 french sheath.During the procedure, a 6 french sheath was used.However, the size should not have interfered with the performance of the balloon catheter.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 determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted 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: 8358203
• Report Number: 1820334-2019-00453
• Device Sequence Number: 2254094
• Product Code: DQY
• UDI-Device Identifier: 10827002522715
• UDI-Public: (01)10827002522715(17)191110(10)7433811
• 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
• Report Date (Section B): 05/06/2019

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: 11/10/2019
• Device Model Number: G52271
• Device Catalogue Number: PTA5-35-135-7-2.0
• Device Lot Number: 7433811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR