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

Model Number G56416

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation = unknown.Pma/510(k) number = k170931.Device evaluated by mfg = 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.

Event Description

As initially reported, during an unknown procedure, a triforce¿ peripheral crossing set tip was damaged (a non-reportable event).Upon receipt and initial evaluation of the device on 18oct2019, the tip was found to be split.Non-sharp kinks were also noted upon return (a non-reportable finding).There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.

Event Description

Additional information was received on 05nov2019 noting that the procedure being performed was a chronic iliofemoral outflow obstruction.The flexor sheath split while trying to cross the lesion.Reportedly, the physician noted that there was one location where he was trying to cross and "you could see the flexor tip get 'hung up' on the lesion".Additionally, resistance during insertion or resistance was not noted.Prior to use, the sheath was adequately prepped and flushed, and the hydrophilic coating was activated.According to the initial reporter, the procedure was completed successfully without any other complications.

Manufacturer Narrative

D11: concomitant products - 9 fr.Performer introducer set,.035 wire guide (brand & length unspecified), atlas 14mm diameter by 4cm length, zilver vena 14*140 stent.Investigation/evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned packaged confirmed that a used kcxs-5.0-35-100-rb-0/0-hc set including 1 cxi catheter and 1 flexor sheath was returned to cook for investigation.Another used cxi catheter from a kcxs-5.0-35-100-rb-0/0-hc set was returned as well; the flexor sheath from this set was not returned.Both returned cxi¿s were kinked.The first cxi had kinks located at 97.5cm, 98.7cm, and 99.4cm from the strain relief.The second cxi had kinks located at 68.4cm and 99.5cm from the strain relief.None of the kinks had sharp edges.The returned flexor was also kinked, and the kink was located at 65.2cm from the check-flo hub.It was confirmed that the flexor sheath tip was damaged, as the tip was split, jagged, and out of round.Additionally, the sheath endhole was not smooth.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.However, a review of the subassembly lot did note two potentially related nonconformances.It should be noted that the affected units were scrapped and not replaced.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ¿the device should not be advanced into a vessel having a reference vessel diameter smaller than the sheath outer diameter.¿ the ifu goes on to say, ¿the device should 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.¿ based on the information provided and the examination of the returned product, investigation has concluded that the cause of this event cannot be traced to the device but to the patient¿s condition.Reportedly, the target lesion was tortuous and fibrotic.We will continue our monitoring of similar complaints and have 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.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
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9225286
• MDR Text Key: 176615791
• Report Number: 1820334-2019-02674
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002564169
• UDI-Public: (01)00827002564169(17)220620(10)9763941
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2022
• Device Model Number: G56416
• Device Catalogue Number: KCXS-5.0-35-100-RB-0/0-HC
• Device Lot Number: 9763941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10