MAUDE Adverse Event Report: COOK INC TRIFORCE PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Model Number	G56419
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation has begun; however, a conclusion is not yet available.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unusual post-thrombotic procedure involving a venous malformation and chronic occlusion of the right iliac vein, a triforce peripheral crossing set was used.The user attempted to cross the area from both jugular and iliac veins but was unsuccessful.Initially, it was reported that the set's catheter kinked in the middle of the case; however, a photo provided by the customer shows what appears to be separation of the sheath included with the set.An unknown sheath and other manufacturer¿s wire guides were also used during the procedure.The procedure was completed; however, the chronic occlusion was never able to be crossed.The initial evaluation of the returned device confirmed separation of the sheath with the inner lining and coils exposed.The radiopaque tip was not returned with the device.Per the physician, nothing unusual was observed during the procedure and the patient is doing fine.The user speculates that the tip of the device may have fallen out on the table.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during an unusual post-thrombotic procedure involving a venous malformation and chronic occlusion of the right iliac vein, a triforce peripheral crossing set was used.The user attempted to cross the area from both jugular and iliac veins but was unsuccessful.Initially, it was reported that the set's catheter kinked in the middle of the case; however, a photo provided by the customer shows what appears to be separation of the sheath included with the set.An unknown sheath and other manufacturer¿s wire guides were also used during the procedure.The procedure was completed; however, the chronic occlusion was never able to be crossed.The initial evaluation of the returned device confirmed separation of the sheath with the inner lining and coils exposed.The radiopaque tip was not returned with the device.Per the physician, nothing unusual was observed during the procedure and the patient is doing fine.The user speculates that the tip of the device may have fallen out on the table.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.One used kcxs-5.0-35-100-rb-mpb/dav-hc set returned.The set was returned with the catheter inside sheath.The catheter was able to be removed from sheath easily.The sheath length in it's current state measured 88.4cm with approximately 5mm of inner liner exiting the distal end of the sheath.There was a kink in catheter shaft at 95.4cm from the strain relief.Additionally, a 1cm flattened section was noticed just below the kink.Additional dfa performed on 24nov2020: a borescope was inserted inside the lumen of the sheath to take a picture of the inside lumen.Additional photos were taken of the sheath tip.From the additional pictures: the coils are visible the distal tip of the introducer is separated.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows one other complaint associated with the complaint device lot.The other complaint (pr 313932) was for another failure mode on the same complaint device.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use ¿the triforce peripheral crossing set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions.This device is also intended for injection.This device is also intended for injection of radiopaque contrast media for purpose of angiography.¿ precautions ¿the device should not be advanced into a vessel having a reference vessel diameter smaller than the sheath outer diameter.¿ ¿the device shall not be forced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ instructions for use: ¿caution: advancing the support catheter into the sheath without a wire guide can easily cause kinking of the catheter.Use extra caution during this process.¿ ¿caution: be sure the wire guide tip is extended beyond the cxi support catheter tip at all times, and the cxi support catheter tip is extended beyond the flexor sheath tip at all times.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that the patient¿s anatomy and the procedure contributed incident.As reported, this was an unusual case, not your usual pts (post-thrombotic).This patient had a venous malformation of the iliac at 9mo old and 30 years later, trying to help the patient.The user attempted to cross from both the jugular and iliac, but unsuccessful.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: TRIFORCE PERIPHERAL CROSSING SET
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10945762
• Report Number: 1820334-2020-02239
• Device Sequence Number: 11449292
• Product Code: KRA
• UDI-Device Identifier: 00827002564190
• UDI-Public: (01)00827002564190(17)220911(10)9875236
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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 Expiration Date: 09/11/2022
• Device Model Number: G56419
• Device Catalogue Number: KCXS-5.0-35-100-RB-MPB/DAV-HC
• Device Lot Number: 9875236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/05/2021
• 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: TERUMO STIFF GLIDEWIRE AND ADVANTAGE WIRE; TERUMO STIFF GLIDEWIRE AND ADVANTAGE WIRE