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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
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 35 lp low profile balloon catheter was used to treat subclavian stenosis.Two balloons were catching on the stent struts and would not cross.A third balloon was used and ruptured at 7 atm, which is under burst rate captured in this medwatch with manufacturer report number 1820334-2017-01795.The lesion was both tortuous and calcified.No unintended section of the device remained inside the patient's body.There were no adverse effects on the patient reported due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, device history record, documentation, drawing, instructions for use, quality control, specifications, and visual inspection of the device was completed during this investigation.One used advance 35 lp low profile balloon catheter was returned for investigation.An attempt was made to inflate the balloon.A pinhole was noted approximately 2.5cm from the distal end.There is no damage to the catheter.The catheter length measured within specifications at 135.5cm.The balloon length measured within specifications at 38mm.The balloon did not burst longitudinally or radially.The balloon did not burst, it had a pinhole in it.The complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.According to the physician, the vessel was tortuous and calcified.Per the instructions for use (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." also, according to the ifu, upon removal from package, inspect the product to ensure no damage has occurred." there is no evidence to suggest the product was not manufactured to current specifications.There is no evidence to suggest all items in the lot or similar devices in the field are nonconforming or defective.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.There is no evidence the product was damaged upon opening.Therefore, based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was human anatomy related.Per a quality risk assessment evaluation no further actions are required.Appropriate personnel have been notified to monitor 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: 6731449
• Report Number: 1820334-2017-01795
• Device Sequence Number: 13634559
• Product Code: DQY
• UDI-Device Identifier: 10827002522791
• UDI-Public: (01)10827002522791(17)200602(10)7961109
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: PTA5-35-135-8-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 70