MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that an advance 14 lp low profile balloon catheter was used for a plain old balloon angioplasty (poba) procedure.The procedure was performed against stenosis in left popliteal artery by contralateral approach from right femoral artery.After the target lesion was dilated with the complaint device several times repeatedly, the physician attempted to dilate the lesion further by applying14 atm pressure to the balloon.Although 14 atm was lower than its defined rated burst pressure of 16 atm, the balloon ruptured.Although the balloon ruptured, the lesion seemed to have been sufficiently dilated.The physician retrieved the catheter, conducted the angiography, and ended the procedure.There was no fragment of the balloon left inside of the patient.The physician stated that the lesion may have been stiff and hard since some calcifications were observed.It was presumed that the direction of the rupture was longitudinal, however, this is not confirmed.It was reported that there were no adverse effects to the patient.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 14 lp low profile balloon catheter was returned for examination.Balloon has burst longitudinally.Inspection of the catheter surface showed no non-conformities.The balloon longitudinally split at the proximal end.Split measures approximately 5.5cm.The length of the catheter balloon measured within specifications.A document-based investigation was performed.Review of the device history record shows six nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number.Per the physician, "the lesion might have been stiff/hard since some calcifications were observed there." per the ifu, "the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage." the device had dilated the vessel several times before bursting.Therefore, based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was human anatomy related.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE 14 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: 6730958
• Report Number: 1820334-2017-01735
• Device Sequence Number: 16368369
• Product Code: DQY
• UDI-Device Identifier: 10827002503387
• UDI-Public: (01)10827002503387(17)180309(10)5704396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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 Model Number: N/A
• Device Catalogue Number: PTAX4-14-170-4-12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1