MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	9395108QD
Health Effect - Clinical Codes	Edema (1820); Thrombosis (2100)
Date of Event	06/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reyl1101 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
On 07/07/2016- per sales representative, facility reported several dvts recently with picc lines.On 7/18/2016 - additional information received from sales representative: the patient had the picc placed in the left upper arm basilica.Report stated that complete occlusive acute deep venous thrombosis was noted in the left brachial vein after symptoms of edema were noted in the entire left arm.Lovenox was administered for the clot and a duplex scan was done of the extremity veins.The picc line was removed and a peripheral line was used for the remainder of the patient's therapy.Patient diagnosis: "kyphoscoliosis and scoliosis/ infantile cerebral palsy - this admission was for posterior spinal implementation and fusion of t3-sacrum".
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, trend 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 was inconclusive; there was no indication that the returned sample was out of specification and no potential cause supporting the complainant reported increase in dvt was observed.The product returned for evaluation was a 5fr t/l powerpicc solo catheter.The sample showed indication of use as dressing residue was seen on the extension tubing and blood residue was seen on the catheter and within the distal tip.The sample was visually inspected for indication of damage, defect, or deformity and none was found.Microscopic examination of the catheter was unremarkable.No sign of defect was observed, the catheter surface appeared similar to a non-complainant sample, and the catheter end appeared to have been cut cleanly.Furthermore, tactile evaluation was unremarkable and the sample was patent to infusion using water and a 12ml syringe.No leakage was observed and flow was similar to a non-complainant sample.Deep vein thrombosis is a known complication in peripherally inserted central catheters and several risk factors outside of the manufacture of the specific product exist.There was no indication that this specific product sample was manufactured outside of specification or may have contained a condition which would have increased the risk of dvt.

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS)
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5818941
• Report Number: 3006260740-2016-00368
• Device Sequence Number: 386505
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: (01)00801741035906(17)160528(10)REYL1101
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2016

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 Expiration Date: 05/28/2016
• Device Catalogue Number: 9395108QD
• Device Lot Number: REYL1101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2016
• Supplement Report FDA Received Date: 08/11/2016
• 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: Life Threatening
• Patient Age: 22 YR
• Patient Weight: 33