MAUDE Adverse Event Report: ACCESS VASCULAR INC. HYDROPICC 5FR DUAL LUMEN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number PICC-251

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Dvt reported for patient with picc-251 device.

Manufacturer Narrative

On (b)(6) 2023, (b)(6) (avi clinical field director) and (b)(6)(avi national sales manager) were at (b)(6), a site participating in the picc-251 (dual lumen) limited market release (lmr).During this visit, a radiologist mentioned that one of the patients had a dvt and went on to state that "it was a difficult placement".For this patient, the vascular access team at riverside had attempted "multiple" times to insert a non-avi picc line catheter without success.The patient was then referred to the ir team to insert an avi picc-251 catheter; it took the ir team "multiple" tries as well but they were able to successfully insert the picc-251 line on (b)(6).Through (b)(6) discussion with the team at riverside, the general consensus was that the dvt was not caused by the product, but rather a vein that was "well used" or "over-manipulated." avi reviewed the picc-251 lmr insertion questionnaire that was completed for the device.In summary: - the clinician (jeffrey mendell) had prior experience with avi catheter kits (>5 insertions).- the patient had a co-morbidity: diabetes.- the catheter was inserted in the left basilic vein, however, the patient was identified as having strictures (v-18 wire could not be withdrawn; v-14 was used to pass a stricture).The clinician rated the "ease of advancement of the catheter" a 3/5 (average).- the clinician determined the device to be clinically acceptable.The device was discarded after removal, therefore not available for evaluation by avi.No patient outcome was noted.The lot number provided, #11423187, is assigned by argon medical (avi's approved supplier for kitting).This kit contained catheters from avi catheter lot #08182206.The lhr for these catheters was reviewed and there were no deviations or nonconformances found that could contribute to the complaint issue.The instructions for use (ls-068 rev c) for picc-251 includes a contraindication for "anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures." consensus from the team at (b)(6) was that the dvt was not caused by the product, but rather a vein with a known blockage that was identified prior to placement of the line.No further action is required.

• Brand Name: HYDROPICC 5FR DUAL LUMEN
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ACCESS VASCULAR INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer (Section G): ACCESS VASCULAR INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 16685340
• MDR Text Key: 312762033
• Report Number: 3015060232-2023-00005
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00850030354044
• UDI-Public: (01)00850030354044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PICC-251
• Device Catalogue Number: 80002002
• Device Lot Number: 11423187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other