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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) the event is currently under investigation.

Event Description

Following an angioplasty procedure, the patient complained of pain.No blood flow in his leg was observed afterwards.The surgeon was not aware that there was a piece of balloon blocking the first graft because the ct following the angioplasty had not been reported on.The ct report showed a piece of balloon in the patient's first graft so he returned to surgery for removal and a second bypass was performed.

Manufacturer Narrative

Lot # is unknown as it was not provided.Exp.Date is unknown as no lot # was provided.Udi # is unknown as it was not provided.(b)(4).Investigation-evaluation: a review of the complain history, instruction for use (ifu), specifications, trends and a visual inspection of the complaint device was conducted for the purpose of this investigation.Two portions of the damaged balloon catheter were returned for investigation.One portion contained the distal end of the shaft (including tip) and a piece of the balloon still attached.The second portion was only part of the balloon (detached from the catheter).The proximal end of the catheter was not returned for investigation.Both separated pieces had dried biomaterial within the balloon.The distal end of the shaft with balloon measured 9 cm in length.The catheter shaft appeared severely stretched.The proximal end of the shaft had a portion that "accordioned" (meaning the shaft had stretched and relaxed/compressed back on itself creating ridges which look like an accordion) and the very proximal end had a split in the shaft up to the accordioned portion.There was a dent/kink in the shaft approximately 2 mm proximal to the most proximal balloon piece.The balloon was scrunched, especially at the distal bond as it had portions that appeared to have folded over itself.The balloon measured approximately 1.6 cm at its longest length, and 8-9 mm at its shortest length.The tip of the catheter measured approximately 3.5 mm which is within spec.The separated balloon piece measured 1.7 cm at its longest length, and 6 mm at its shortest length.The proximal end with bond was missing from the balloon.There was an incomplete circumferential tear about 7 mm in from the distal end of the balloon.When the separated balloon piece was matched to the balloon on the catheter, the entire length measured approximately 2.7 cm in length, indicating some of the balloon was not returned.It is possible that the missing piece of the balloon is still present on the proximal portion of the shaft as the proximal end of the balloon was not present.The balloon appeared to have ruptured and separated circumferentially.Balloon burst, compliance, and fatigue verification testing have been performed.The rated burst pressure (rbp) is documented in the compliance card and label.The balloon is inspected and verified for smoothness, clean, and free of damage.Each device is shipped with ifu which states the appropriate uses, contraindications, warnings and precautions, and proper usage procedures including proper inflation and deflation procedures.The ifu states: "do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur." the ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The description of event did not indicate a rupture, but patient event/info notes stated the following question and answer, thus indicating a rupture occurred: "did the balloon burst circumferentially or longitudinally? ¿ we think circumferentially." the inflation pressure was not known as the additional questions indicate that an inflation device was not used.The rated burst pressure (rbp) for this device is 15 atm.If the rbp was exceeded during use, then over-inflation could have contributed to the balloon rupture.Balloons are designed to rupture linearly, but may burst or tear circumferentially due to angulation or calcification.Calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to burst or tear.The patients anatomy was not reported.Based on inspection of the returned device, the balloon appeared to have burst and/or tore circumferentially.Balloon rewrap becomes more difficult if the balloon bursts, especially for a circumferential burst or tear.If the user attempted withdrawal through an introducer/sheath (against the ifu) balloon rewrap through the sheath would be more difficult increasing the potential for separation.The method of attempted device removal was not reported.Without additional information, a definitive root cause cannot be determined.No remedial action is required at this time.We have notified appropriate internal personnel and will continue to monitor for similar complaints.

Event Description

Following an angioplasty procedure, the patient complained of pain.No blood flow in his leg was observed afterwards.The surgeon was not aware that there was a piece of balloon blocking the first graft because the ct following the angioplasty had not been reported on.The ct report showed a piece of balloon in the patient's first graft so he returned to surgery for removal and a second bypass was performed.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5021065
• MDR Text Key: 23694371
• Report Number: 1820334-2015-00499
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/29/2015

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-5-4.0
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1