MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Spinal Column Injury (2081); Thrombus (2101); Tingling (2171); Discomfort (2330); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebs1135 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported a patient with a right arm picc presented (b)(6) 2019 with a swollen upper right arm with tingling and cold fingers.Upper extremity doppler ultrasound showed partial collapse of the brachial /axillary vein around the picc and a small amount of non-occlusive thrombus in the deep subclavian vein.The picc has been position for 14 months without significant incident and was used for elastomeric pump delivery of irinotecan 5fu chemotherapy.The picc was found to be working well and the patient was started on daily therapeutic tinzaparin by the oncology team.The patient presented 3 days later with persistent symptoms swelling around the bicep, tenderness in the ante cubital fossa region and numbness in the little and ring finger of the right hand.Pulses were normal in the radial and afc with capillary return of 2 seconds in the fingers.There were no signs/symptoms of extravasation in the right arm.Again the picc aspirated and flushed without difficulty.Given continuing symptoms picc was removed and found to have a large split at the point which would have laid in the axillary vein.The oncology anps stated the patient did have a staging ct scan on the same day he underwent doppler scan.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a split in catheter was confirmed and the cause appears to be use related.The product returned for evaluation was a 4fr s/l powerpicc solo catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed between the 19cm-20cm depth markings.The catheter split was typical of flexural fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear.'c' shaped impressions leading into the fracture site which are consistent with material.Buckling due to movement which caused the fracture edges to be pressed together.Overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

Event Description

It was reported a patient with a right arm picc presented (b)(6) 2019 with a swollen upper right arm with tingling and cold fingers.Upper extremity doppler ultrasound showed partial collapse of the brachial /axillary vein around the picc and a small amount of non-occlusive thrombus in the deep subclavian vein.The picc has been position for 14 months without significant incident and was used for elastomeric pump delivery of irinotecan 5fu chemotherapy.The picc was found to be working well and the patient was started on daily therapeutic tinzaparin by the oncology team.The patient presented 3 days later with persistent symptoms swelling around the bicep, tenderness in the ante cubital fossa region and numbness in the little and ring finger of the right hand.Pulses were normal in the radial and afc with capillary return of 2 seconds in the fingers.There were no signs/symptoms of extravasation in the right arm.Again the picc aspirated and flushed without difficulty.Given continuing symptoms picc was removed and found to have a large split at the point which would have laid in the axillary vein.The oncology anps stated the patient did have a staging ct scan on the same day he underwent doppler scan.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET F
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8404866
• MDR Text Key: 138275088
• Report Number: 3006260740-2019-00516
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741102660
• UDI-Public: (01)00801741102660
• Combination Product (y/n): N
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000375
• Device Lot Number: REBS1135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention