MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G30946

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: other non-healthcare professional: ors periop quality specialist.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during an angioplasty a advance 18 lp low profile balloon catheter became lodged on a wire guide, which led to the balloon port detaching.As the user was advancing the balloon catheter over the wire when it became stuck.Then as they attempted to dislodge the catheter the balloon port detached.The balloon then had to be cut to remove the device and the wire.No portion of the device was left in the patient.This did not result in additional procedures or prolonged hospitalization.The patient did not experience any adverse effects.

Manufacturer Narrative

D10: concomitant products= bentson wire, 0.035" glidewire, 0.035" quickcross catheter, v18 wire, v14 wire, 0.018" quickcross, 0.014" quickcross, bern catheter, 6 french 45-centimeter ansel-2 sheath, 0.018" spectanetics atherectomy catheter, omniflush catheter h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was available and inadvertently omitted from the initial mdr: as reported, during an angioplasty, an advance 18 lp low profile balloon catheter became lodged on a wire guide.Access was obtained in the left common femoral artery under ultrasound guidance, using a 21-gauge needle and unknown micropuncture device.A bentson wire was advanced, and an unknown 6 french short sheath was placed.A catheter was advanced into the aorta and an aortogram was performed.An angiogram of the right lower extremity was then obtained from the right external iliac artery.The short sheath was exchanged for a 6 french ansel, over the bentson wire.A 0.035-inch wire and crossing catheter were advanced into the right superficial femoral artery.The devices were noted to be in a subintimal plane and were advanced to the distal superficial femoral artery.At that point, the devices would not cross further due to extensive calcification.Additional access was obtained in the right posterior tibial artery with a pedal access kit, and an angiogram was performed.Another manufacturer¿s wire and 0.018-inch crossing catheter were advanced; however, that catheter would not cross the calcified area.Another manufacturer¿s catheter was then advanced but would line up within the same plane.Another manufacturer¿s 0.014-inch wire and crossing catheter were then advanced and were able to cross the calcified area from below.A 0.018-inch wire was then advanced into the proximal superficial femoral artery distal to the occlusion.The wire was captured with a snare from above to obtain through-and-through access.Another manufacturer¿s 0.018-inch atherectomy device was used to treat the calcified right superficial femoral artery two times.The cook advance 3-millimeter balloon was then advanced from above and the entire posterior tibial artery to the tibioperoneal trunk was treated with serial dilations of three-minutes each.At some point during this procedure, the balloon became stuck on the wire guide.While attempting to dislodge the balloon, the port detached.The balloon catheter was cut by the user in order to successfully remove the wire and entire balloon catheter from the patient.An unknown 4-millimeter balloon was then used to treat the entire popliteal artery above and below the knee with three-minute inflations.A five-millimeter balloon was then used within the proximal popliteal artery and the entire superficial femoral artery, with inflations also lasting three minutes.A repeat angiogram showed inline flow with two-vessel run-off to the foot from the posterior tibial and peroneal arteries.Pressure was held at the posterior tibial access site for fifteen minutes.The femoral sheath was exchanged for a 6-french short sheath over the bentson wire.An angiogram of the groin was obtained, and the sheath was removed, and pressure was held for twenty-five minutes.An open procedure followed, involving exploration and sartorius myoplasty of the right groin with placement of antibiotic beads, exploration of the right calf with debridement of necrotic skin and muscle, and wound-vac placement.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: it was reported that an advance 18 lp low profile balloon catheter became lodged onto a wire guide.While attempting to dislodge the balloon, the port detached.The balloon catheter was cut by the user to successfully remove the wire and entire balloon catheter from the patient.The procedure was completed with multiple other devices.No adverse effects to the patient were reported as a result of this incident.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, specifications, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One pta4 balloon was returned for investigation.The device was received separated into three sections, and the proximal fitting was separated.One section of tubing was lodged on an unknown wire guide.All separation points on the tubing were jagged and torn in appearance.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The device is provided with instructions for use which provide the following: balloon preparation: ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation: ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ based on the available information, cook has concluded that the patient¿s anatomy was the primary contributing factor to this incident.The reported vessel occlusion and extensive calcification likely caused the balloon to become stuck on the wire.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11629332
• MDR Text Key: 245593369
• Report Number: 1820334-2021-01090
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309460
• UDI-Public: (01)10827002309460(17)231203(10)13603174
• Combination Product (y/n): N
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Model Number: G30946
• Device Catalogue Number: PTA4-18-150-3-20
• Device Lot Number: 13603174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 72