MAUDE Adverse Event Report: COOK INC Cook Spectrum Turbo-Ject

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Turbo-ject single lumen minocycline/rifampin over-the-wire power-injectable picc.Ljs turbo-ject peripherally inserted central venous catheter.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that the picc line burst distally during flushing.The patient was taken to the interventional radiology (ir) department and the fragmented portion was retrieved with a snare.There was no harm to the patient and post procedure the patient is doing "okay.".
Additional Manufacturer Narrative
One competitor product and 2 used catheters were returned to assist in the investigation.The first catheter showed damage along the length of the catheter shaft.The catheter swelled in size at four locations along the length.The largest of the three swollen locations show signs of a longitudinal split.The largest of the swollen sections circumferentially separated.Functional testing with a wire guide reveals the device was occluded at the hub, the distal tip and at the proximal end of the distal segment of the catheter.The second returned catheter burst longitudinally at approximately 54cm distal of the strain relief used catheter was occluded at the distal tip.Bio matter was present inside both products indicating that both were likely used.Four unopened devices were returned to assist in this investigation.One device was functionally tested and the other 3 will be retained unopened for archiving purposes.One unopened device was clamped at the distal tip.Water was forced into the catheter to a psi of 25 for 30 seconds with no rupture occurring.Catheter shaft visibly expanded along the length to accommodate this pressure.Pressure was release and then the catheter reinflated to a psi of 22 when a longitudinal rupture occurred along the catheter shaft.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of 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.Based on the information provided, occlusion of the device likely led to the initial swelling and longitudinal ruptures.It is feasible to suggest that the first of the used catheters circumferentially separated during removal.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: Cook Spectrum Turbo-Ject
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5986412
• Report Number: 1820334-2016-01030
• Device Sequence Number: 10786342
• Product Code: LJS
• UDI-Device Identifier: 00827002345546
• UDI-Public: (01)00827002345546(17)171111(10)6949080
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-OTW-ABRM-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 09/29/2016
• Supplement Report FDA Received Date: 07/13/2017
• 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