MAUDE Adverse Event Report: COOK INC TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Catalog Number UPICS-4.0-CT-OTW-ST-1111

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a turbo-ject® single lumen over-the-wire power-injectable picc kinked in a sharp angle and was impossible to unkink.Upon removal of the device, the wire guide unraveled.After removal, a 2cm fragment of the wire guide remained in the superficial soft tissue.It is unknown if the reported 2cm fragment remains in situ or has been removed.To date, additional information with regards to the patient and device have been requested but not yet provided.As reported, the patient was unable to utilize another picc line due to thrombosis.

Manufacturer Narrative

Device evaluation: the used device was returned to cook inc.For evaluation.Visual inspection noted a kink in near the distal tip and the distal tip weld on the guide was missing.The mandril was deemed broken in and the coils were said to be elongated.Investigation: a document-based investigation reviewed the following: instructions for use, quality control, specifications and manufacturing instructions.A review of the device history record of the finished product and a complaint history was unable to be performed as the lot number for the device was not available.A search of global sales shipments with lot numbers to the customer showed there were products from 4 lots delivered since 01jan2015: 5687241, 5764350, 5767796, and 5939408.It can be assumed that the complaint device came from one of these 4 lots based on the three year shelf life of the device.Cook searched for additional related complaints from these lots and no additional complaints have been reported.Additionally there were no nonconformances related the reported failure mode noted in the devices that were released to the market.Based on this information, there is no evidence that suggests there are non-conforming products in house or in field.Cook conducted verification testing for this type of wire guide, and the guide was able to withstand the load force specified in the acceptance criteria for the tensile test.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.Conclusion: it was stated by the customer that during the procedure, the wire was manipulated through the needle in the kit.The wire was returned with elongated coils, an intact proximal solder, and a missing distal weld.There is no evidence to suggest the device was not manufactured to specifications.It is likely that manipulation of the guide lead to the break in the wire guide near the tip, leading to the kink and separation of the guide when removal was attempted.This event can be attributed to an unintended use error.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.

Manufacturer Narrative

Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.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.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.

Event Description

On (b)(6) 2018 the customer reported that the wire guide (access wire) partially exited the vein during use and was manipulated through the kit needle.The patient had lung cancer and the surgical team is planning to remove the device fragment at a later date.The facility has been requested to inform cook inc.When this procedure takes place.Another picc line was not inserted as the patient has bilateral thrombosis.

• Brand Name: TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC
• Type of Device: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8009205
• MDR Text Key: 125137937
• Report Number: 1820334-2018-03096
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K132334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2018

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 Catalogue Number: UPICS-4.0-CT-OTW-ST-1111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 11/06/2018; 12/12/2018
• Supplement Dates FDA Received: 12/06/2018; 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other