MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G26407
Date of Event	04/04/2019
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, a (b)(6) male was undergoing an angioplasty procedure of a tibial vessel via pedal access.Patient's anatomy was described as severely calcified.Angulation and tortuosity were minimal.Upon removal from the patient's anatomy, the shaft of an advance micro ¿ 14 ultra low-profile pta balloon catheter broke in half.This occurred outside the body.Other devices used were a 5fr cook pedal access sheath and another manufacturer's inflation device and guide wire.Visipaque contrast in a 50/50 ratio with saline was also used to inflate the balloon.Ultimately the procedure was aborted reportedly because it was a difficult procedure and the physician was subintimal with the other manufacturer's wire.The complaint balloon was removed with the wire and the sheath with difficulty due to resistance.According to the complainant, the patient did not experience any adverse effects nor require other intervention as a result of this occurrence.
Event or Problem Description
Additional information received noting that negative pressure was applied while attempting to remove the balloon catheter.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 conformed that the complaint device was returned in two separate pieces.An unknown wire guide extended out either end of the distal piece.The proximal portion of the shaft was consistently narrow until a small portion of the shaft was accordioned.The narrow portion was believed to be the inner shaft material.No damage was visualized on the proximal portion of the device, outside the point of separation.An axial view at the point of separation showed only one lumen.Therefore, the inner and outer shaft separated in two different areas of the device.The proximal end of the wire lumen could be seen within the hub, this suggested that the adhesive used in the proximal glue was adequately placed.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 also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the drawings and quality control procedures were conducted, and no gaps were discovered.Moreover, the product labeling was reviewed and the values and indications on the box packaging was determined to be accurate and descriptive of the device.The instructions for use, included in each product, was assessed.It is noted that the device is indicated for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries; including internal pudendal, iliac, renal, popliteal, infrapopliteal, femoral, iliofemoral, anterior tibial, peroneal, pedal, radial, brachial, and ulnar; and obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The ifu specifically calls out that it is not intended for coronary arteries.Then goes on to say if resistance is felt during withdraw, negative pressure should be applied to the balloon.If resistance continues, it should be removed with the sheath as a unit.Negative pressure is believed to be applied, however, the sheath and balloon catheter were not removed together as a unit.There is no evidence that the device was manufactured incorrectly and there is no evidence that the materials used were inadequate.Although it is believed that negative pressure was applied to the device, the sheath and balloon catheter were not removed together, as specified in the instructions for use.The shaft separation was determined to be the result of the customer not removing the balloon catheter and sheath together after resistance was felt.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.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 MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8509887
• Report Number: 1820334-2019-00810
• Device Sequence Number: 19313069
• Product Code: DQY
• UDI-Device Identifier: 10827002264073
• UDI-Public: (01)10827002264073(17)210614(10)8950549
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

1 Device 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: 06/14/2021
• Device Model Number: G26407
• Device Catalogue Number: PTA3-14-90-2.5-10
• Device Lot Number: 8950549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No