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

Model Number	G52270
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that during a right lower extremity angiogram, the advance 35 lp low profile balloon catheter ruptured after inflation over the rated burst pressure (rbp) of 10 atmospheres (atm).The patient was a (b)(6) year old, non-obese male.The left groin was accessed with a 6 french (fr) sheath up and over to the right common femoral artery (cfa).A stiff glide wire was used down the superior femoral artery (sfa) status post 1.5mm crown csi atherectomy device.The complaint device was used for pre-dilation of the vessel and was inflated in the popliteal artery/distal sfa and overlapping inflations in the mid sfa and proximal sfa.The second two inflations were at 16 atm which is above the rbp.The vessels were severely calcified and on the third inflation at 16 atm, the complaint device ruptured longitudinally.The advance 35 lp low profile balloon catheter was exchanged out for a different balloon for post dilation of the vessel after the stent was deployed.Per the complainant, the procedure was completed successfully.No portion of the complaint device remained in the patient's anatomy and no additional procedures were required.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a kink, which was noted a distance of 2.2 cm proximal to the proximal balloon bond.A leak was also noted in the catheter at a distance of 6 mm proximal to the proximal balloon bond.The balloon did not appear to have ruptured.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 be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 7554114
• Report Number: 1820334-2018-01560
• Device Sequence Number: 179210
• Product Code: DQY
• UDI-Device Identifier: 10827002522708
• UDI-Public: (01)10827002522708(17)201106(10)8351830
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: G52270
• Device Catalogue Number: PTA5-35-135-6-14.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR ANSEL SHEATH, 0.35 STIFF ANGLED UNIGLIDE WIRE; 6FR ANSEL SHEATH, 0.35 STIFF ANGLED UNIGLIDE WIRE
• Patient Age: 66 YR