MAUDE Adverse Event Report: COOK INC TURBO-JECT POWER INJECTABLE; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Occupation: unknown.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a turbo-ject power injectable device was being used on a patient when a piece of the wire guide broke off.This reportedly occurred during placement of the picc line.The guide was retrieved using a "lasso and crocodile clip".The picc line had to be removed.A new device was unable to be placed, as the blood vessels were weakened during the search for the broken wire fragment.There was no additional treatment needed for the weakened blood vessels.As reported, no other adverse effects were experienced by the patient due to this occurrence.
Additional Manufacturer Narrative
Additional information: concomitant medical product received on: 23sep2019.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 or Problem Description
No additional information has been received regarding patient and/or event details since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.E4 - reported to regulatory agency: yes.Investigation - evaluation.A review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications, as well as a dimensional verification and visual inspection of the returned device, were conducted during the investigation.The distal tip portion of a wire guide was returned to cook for investigation.Visual inspection revealed that the distal weld connection was present and attached.Elongation was noted on the other end.The returned device is the portion of the wire guide that migrated and had to be retrieved within the patient.The complaint was able to be confirmed based on inspection of the returned device as well as customer testimony.There is no evidence to suggest that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for lot 9846835 revealed no non-conformances.However, one non-conformance for the sub-assembly wire guide lot (ic9679210) regarding a broken weld tip was found.This affected a total of three devices that were disposed of.A database search found no additional complaints for lot 9846835.As a result of these findings, cook has concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling related to the complaint device.The product¿s instructions for use, t_ctpiccotw_rev8, provides the following information to the user related to the reported failure mode: precautions: -¿the product is intended for use by health care practitioners trained and experienced in proper positioning of catheters in the central venous system using percutaneous entry (seldinger) technique.Standard technique for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.¿ how supplied: -¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned product, and the results of our investigation, a definitive root cause could be traced to component failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 or Problem Description
No additional information regarding the patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: TURBO-JECT POWER INJECTABLE
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9076026
• Report Number: 1820334-2019-02347
• Device Sequence Number: 16763632
• Product Code: LJS
• UDI-Device Identifier: 00827002561946
• UDI-Public: (01)00827002561946(17)210630(10)9846835
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1110
• Device Lot Number: 9846835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 09/23/2019; 10/25/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/11/2019; 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention