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 Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a post tpa drip using an advance 35 low profile balloon catheter, the balloon got stuck in the patient's iliac vein.It was stated that there was angulation to the iliac vein.When pulled negative, blood came into syringe.The device shaft was cut and the wire was reinserted.The balloon had to be retrieved and snared from the opposite side.No unintended section of the device remained inside the patient's body and there were no reported adverse events due to this occurrence.
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.The balloon catheter was returned in three sections.The 1st section (proximal) is 94.6cm in length.Hub and strain are attached and not damaged.Kinks are noted at 7.2cm, 44.0cm and 57.0cm from the proximal end.The 2nd section (midsection) is 32.3 cm in length.It should be noted the customer stated they cut the balloon.The proximal portion of the balloon is attached to this section.Kink is noted at 8.0cm, measuring from proximal end of the midsection.2.8cm of the balloon is attached to the distal end of the midsection.The 3rd section (distal) is 16.9cm in length.The distal portion of the balloon is attached to this section.A compression is noted 2.4cm from the proximal end of this section.The compression measure 4mm in length.Kink is noted at 8.4cm from the proximal end of this section.Balloon is 8.0cm in length.The balloon ruptured radially.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The customer stated, "a sheath was used.It was unknown if a wire guide was in place during attempted removal; once deflated, the balloon was allowed to return to ambient pressure; upon balloon catheter withdrawal, it is unknown if a clockwise rotation of the balloon conducted; there was a lesion located in the iliac vein and there was angulation of the device." per the ifu, "if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." based upon the information provided regarding the lesion located in the iliac vein and there was angulation of the device, it is plausible to suggest that this incident was human anatomy related or technique 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 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: 6681572
• Report Number: 1820334-2017-01343
• Device Sequence Number: 16189772
• Product Code: DQY
• UDI-Device Identifier: 10827002522821
• UDI-Public: (01)10827002522821(17)191115(10)7444681
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-135-8-10.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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
• Patient Age: 72 YR
• Patient Weight: 79