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

Model Number	G52360
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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) male weighing (b)(6) with medical history of diabetes (type unspecified), underwent balloon angioplasty and stent placement in the external iliac artery.The vessel was tortuous and highly calcified.Angulation was reported.Prior to this procedure, it was determined the patient would require an open bypass procedure.The stent (manufacturer unknown) was properly expanded.The advance 35 lp low profile balloon catheter was inflated inside the stent using a cook inflation device.The complaint balloon was quickly inflated and ruptured circumferentially at 8 atmospheres (atm).A slight tinge of blood was noted in the inflation device.The type and ratio of the inflation medium was not provided.The complaint balloon was removed over a wire and along with the sheath.A portion of the balloon could not be removed and remained in the patient's anatomy.The physician will remove it during the open bypass procedure which is schedule on (b)(6) 2019.The patient did not experience any adverse effects as a result of this occurrence.
Additional Manufacturer Narrative
Additional information: event - it was provided the patient underwent the bypass procedure on (b)(6) 2019 where the portion of the complaint device was successfully removed.The patient is reportedly doing well.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.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.A review of the functional test, complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon separated.Biomatter was present throughout the device.The shaft measured 72 centimeters from the distal end of the strain relief to the balloon and the balloon measured approximately 3.2 centimeters from the proximal bond to the point of separation.The proximal marker band is present inside the balloon portion.No other device portions were returned for evaluation.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 one nonconformance for proximal bond damage.While this could contribute to this failure mode, the affected device was scrapped and not replaced.It should be noted there were no other reported complaints for this lot number.The device is provided with instructions for use (ifu).Per the ifu, the complaint device is intended 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.Inflation inside stents is not included in the ifu.The ifu also states that if balloon pressure is lost and/or balloon rupture occurs, the balloon should be deflated, and the balloon and sheath should be removed as a unit.In this case, the complaint device was used/inflated inside of a stent, which is not included in the indications for use within the ifu.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, the cause of this event cannot be traced to the device; but rather can be traced to inflation of the device inside a stent as well as the patient¿s highly calcified anatomy.Appropriate measures have been initiated to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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: 8361530
• Report Number: 1820334-2019-00455
• Device Sequence Number: 19331537
• Product Code: DQY
• UDI-Device Identifier: 10827002523606
• UDI-Public: (01)10827002523606(17)210913(10)9159927
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2019

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: 09/13/2021
• Device Model Number: G52360
• Device Catalogue Number: PTA5-35-80-8-6.0
• Device Lot Number: 9159927
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/06/2019; 04/22/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/07/2019; 04/23/2019
• 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: BOSTON SCIENTIFIC 6FR SHEATH; BOSTON SCIENTIFIC 6FR SHEATH
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 84