MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PTA5-35-80-10-2.0

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant products: 0.35 glidewire (terumo), 6fr sheath (cook).According to initial reporter, the complaint device is not available for return.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

An (b)(6) female with past medical history of diabetes (type not specified), peripheral vascular disease, and renal failure (unspecified) underwent a balloon angioplasty of the right iliac artery to clear an intrastent stenosis.During the procedure, the advance 35 lp low profile balloon catheter ruptured when inflated to nominal pressure.The patient required a cut-down procedure in order to remove the complaint device.The procedure began by accessing the left groin in a contralateral manner in order to reach the stented right common iliac artery.The stent was present in the distal common iliac artery into the external iliac artery.The advance 35 lp low profile balloon catheter was inserted through a 6fr (french) sheath into the treatment area and inflated to nominal pressure when it ruptured circumferentially.The artery was being ballooned above the stent.Reportedly, there seemed to be a fracture of the stent on the outside wall distal to the ballooned portion of the artery.An attempt was made to remove the complaint device but it would not move backward or forward on the 0.35 wire, necessitating both the wire and the complaint device being removed together.Both the complaint device and the wire were withdrawn, but would not fit through the sheath.The tip of the complaint device seemed to bunch up.Because the physician determined further removal attempts would damage the artery, the patient was taken to the operating room where an arteriotomy was performed to successfully remove the sheath and balloon.The artery was repaired with sutures.According to the complainant, there was a small amount of calcification in the vessel but no angulation.

Event Description

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

Manufacturer Narrative

Concomitant medical products: on the initial mdr, this field was inadvertently marked 'yes' rather than no.This field has been updated.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use(ifu), manufactures instructions, quality control, specifications, and a visual inspection of the device was conducted during the investigation.The visual inspection of the images provided confirmed that the that the balloon has ruptured circumferentially around the entire device.From the images, it is unknown whether any longitudinal tears are present.The catheter portion where the balloon is attached appears to be lighter in color, suggesting the material has been stretched.This is congruent with the customer stating they had difficulty removing the balloon catheter through the sheath and stretched the catheter in the process.One marker band can be observed.Because of the presence of biomatter and configuration of the balloon, the second marker band cannot be visualized.The customer reported that no portion of the balloon catheter remained inside the patient.One, gray wire guide can be seen extending out of the distal tip of the catheter, as reported in the complaint file.Additionally, because the complaint device was not returned, no physical examinations could be performed.However, 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 shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, an ifu is provided with the device, which includes a warning against using pressures greater than the rated burst pressure, which may result in a rupture.An introducer sheath of the appropriate size, may be utilized.Upon opening and removing the device, inspection of the catheter is required to ensure no damage has occurred during shipping.Based on the information provided, no product returned and the results of our investigation, a definitive root cause cannot be traced to a fault in the device.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed in section h10.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.A hhs/fda 3500a mandatory/voluntary event form report reference 1600580000-2018-8003 was received on 10/12/218 which reported: "a 10x20 mm balloon broke inside the patient's artery during routine use in the cath lab.The balloon could not be removed and patient was taken emergently to or (operating room) for right groin cut-down and surgical removal of broken balloon." this voluntary medwatch listed the procedure at the time of this event as a cardiac catheterization; however, the original report was for an angioplasty of a re-stenosed stent in the common iliac artery.During follow up with the initial reporter of the voluntary medwatch, the initial reporter stated that the initial manufacturer's mdr and the voluntary medwatch are for the same event.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.- attachment: [pr 243222_hhs_fda_3500a_160058000020188003_recvd 12oct2018.Pdf].

• Brand Name: ADVANCE 35 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: 7886175
• MDR Text Key: 120693838
• Report Number: 1820334-2018-02760
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343730
• UDI-Public: (01)10827002343730(17)210104(10)8486582
• Combination Product (y/n): N
• PMA/PMN Number: K132020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Catalogue Number: PTA5-35-80-10-2.0
• Device Lot Number: 8486582
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 08/29/2018; 10/12/2018
• Supplement Dates FDA Received: 11/01/2018; 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 80