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

Model Number	G52373
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number = 17184.(b)(4).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 (b)(6) year-old male was undergoing a percutaneous stent placement and percutaneous transluminal angioplasty (pta) procedure.Access was obtained from the left femoral artery to the lesion located in the right iliac artery with a retrograde approach.Another manufacturer's 0.035-inch wire guide was passed through the lesion and pre-dilatation was performed using another manufacturer's 9mm-40mm balloon catheter, followed by placement of another manufacturer's 10mm-60mm stent.Post-dilatation of the stent was performed using the complaint device, an advance 35 lp low profile balloon catheter.Upon initial inflation of the complaint device, it ruptured circumferentially at 8 atmospheres (atm).When the physician attempted to remove the device from the patient¿s body, resistance was felt and the tip of the complaint balloon catheter became separated as it was being pulled back into the sheath.According to the cook representative, the complaint balloon could not be rewrapped due to it's rupture.The physician used another manufacturer's 7fr sheath to cover the separated tip and remove it from the patient¿s body.The procedure was completed successfully by performing the post-dilatation with the balloon catheter previously used for the pre-dilatation.No sections of the complaint device remained in the patient¿s anatomy.Although requested, information regarding the device used to inflate the complaint balloon and, type and ratio of contrast were reportedly not known.
Additional Manufacturer Narrative
Corrected information: method, results, and conclusion codes.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.
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
Additional information: investigation - evaluation.A review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 35 lp low profile balloon catheter was returned for investigation; biomatter was present throughout the device.The device was returned in four separate pieces, but not including the hub and most proximal portion of the balloon catheter.The visual inspection of the returned device confirmed that the balloon had ruptured and separated.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 two nonconforming events; however, they do not appear to be related to the reported failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.The device is also provided with instructions for use (ifu).The ifu states that the intended use of this device 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." the ifu also states as a step for balloon introduction and inflation, "5.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." the complaint will be confirmed based on customer testimony as well as an examination of the returned device.Based on the information provided and the examination of the returned product, investigation has concluded the cause of this event cannot be traced to the device; the inflation of the balloon inside of the stent in this procedure potentially led to the failure.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 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.
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: 8322244
• Report Number: 1820334-2019-00355
• Device Sequence Number: 1500178
• Product Code: DQY
• UDI-Device Identifier: 10827002523736
• UDI-Public: (01)10827002523736(17)191227(10)7546716
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2019
• Device Model Number: G52373
• Device Catalogue Number: PTA5-35-80-10-4.0
• Device Lot Number: 7546716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 04/10/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/10/2019; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PREVIOUSLY STATED; PREVIOUSLY STATED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR