MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC VERSA-KATH; CATHETER

Model Number A-EP-042

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, (b)(6) emailed epimed stating that they had an account that reported the pet inner coating (b-tu-005) on two different versa-kath catheters was different in length.Mr.(b)(6) stated that the reporting hospital had used one of the versa-kath's during a procedure and that the patient became neurolepsis.The physician stated that "if the gray (pet) coating is shortened, it is hard to reach the target, so it bends in the body and touches other nerves when targeting." mr.(b)(6) stated that (b)(6) had received two sample catheters from the reporting hospital for comparison analysis of the pet coating.One catheter sample was a 12" versa-kath (lot 11128891) and the second catheter sample was a 24" versa-kath (lot 11248832).Mr.(b)(6) provided a picture of the two devices to epimed.After review of the supplied picture, it was evident that the gray pet coating length between the two devices differed in length.However, versa-kath specifications, a tolerance of up to.50" is allowed between the distal end of the catheter's pet coating and the proximal end of the catheter's distal spread.Therefore, the lengths of the pet coating can differ between different catheters and/or catheter lots.The batch history records for the reported catheter lots were immediately reviewed; revealing no abnormalities within the reported lots.All inspection and testing passed successfully.The pet coating is supplied to epimed.A review of the supplier files along with review of previous revisions of the product specifications for the pet coating revealed no changes made in regard to coating material or coating wall thickness.After receipt of the mr.(b)(6)'s email, epimed immediately mr.(b)(6) and requested the catheter samples to be returned to epimed for measurement testing.However, no response to the email was received.A follow-up email was sent to mr.(b)(6) on january 31, 2019 requesting any additional information regarding the reported complaint; however, as of february 1, 2019, no response or additional information regarding the reported complaint was received by epimed.Next, the previous 5 years of complaint history was electronically reviewed for similar complaints; however, no similar complaints were found.The reporting account stated that the patient had experienced neurolepsis and the physician reported that it was due to the differing lengths of catheter coating.As a precautionary measure, epimed has filed this mdr regarding the reported event.Due to the fact that the reported devices were not returned to epimed for testing, a more definitive root cause could not be determined.However, based on all available evidence, epimed suspects that end-user error led to the report of neurolepsis of the patient; not the design of the catheter.Epimed will follow-up with the reporting account for a period of two more months in an attempt to acquire any additional information regarding the reported complaint.

Event Description

"the hospital informed us that gray coating part of the two products is different from the older versions.So, we randomly checked these products in the box and we found that the gray coating of the old version's product is covered up to the front of the spring, but the latest version's gray coating is irregular length.Some are short and some are long, we cannot figure out how many quantities are different from older version.Seriously, the hospital is faced with an unexpected serious situation now.The patient became neurolepsis.".

• Brand Name: VERSA-KATH
• Type of Device: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: kris knapp ; 141 sal landrio drive; johnstown, NY 12095
• MDR Report Key: 8298857
• MDR Text Key: 134862485
• Report Number: 1316297-2019-00001
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00818788021397
• UDI-Public: 00818788021397
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K023140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2023
• Device Model Number: A-EP-042
• Device Catalogue Number: 156-2112
• Device Lot Number: 11128891
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 02/01/2019
• 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