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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt identifier) information not provided by reporter.Age at time of event, date of birth) information not provided by reporter.Sex) information not provided by reporter.Weight) information not provided by reporter.(b)(4).The event is currently under investigation.
Event or Problem Description
The balloon burst and ripped in two parts at 13 atm while dilating.The parts were recovered with an 8 fr.Introducer and snare.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, drawing, instructions for use (ifu), specifications, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: "the advance 35lp low profile pta balloon dilation catheter is indicated 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 precautions, "the catheter is not intended for the delivery of stents.All stents should be deployed in accordance with the manufacturer¿s indications and instructions for use.The visual inspection of the returned device reported the affected product shows signs of longitudinal split and circumferential separation.Proximal balloon segment measures approximately 1.2 cm in length.Distal balloon segment measure approximately 2.4 cm in length.The balloon was reported to be inflated to 13 atmospheric pressure (atm) against the ifu and used in stent deployment, also against the ifu.Over inflation likely lead to rupture, and the stent likely caused the rupture to occur circumferentially rather than longitudinally.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation the root cause was failure to follow instructions.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
The balloon burst and ripped in two parts at 13 atm while dilating.The parts were recovered with an 8 fr.Introducer and snare.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5663926
• Report Number: 1820334-2016-00325
• Device Sequence Number: 16220069
• Product Code: DQY
• UDI-Device Identifier: 10827002522784
• UDI-Public: (01)10827002522784(17)181005(10)6259577
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-135-8-2.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2016
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention