MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 3MM X 12CM

Catalog Number	DLF180312
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of one products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01060.
Event or Problem Description
As reported by an affiliate, during a coil embolization of the major aortopulmonary collateral arteries (mapca) at the collateral circulation coming from the right internal mammary artery, a 4mm x 12cm galaxy g3 coil (gly120412, l12742) was used, but the green system ready light did not illuminate.Therefore, it was replaced with another galaxy g3 coil.Then, the coil of a 3mm x 12cm deltafill 18 (dlf180312, l13558) prematurely detached inside the sheath introducer.Therefore, this coil was also replaced with another coil.There was no reported patient injury and the procedure was completed.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr follow up submission #1 is to update sections b5, d10, e1, e2, e3, g4, g7, h2, h3 and h6.Section b5: additional information received indicated that the devices were prepped as per the instructions for use.There had been no packaging issues.The coil delivery systems were prepped without any difficulty.Pre-deployment electrical testing was performed with the galaxy g3 4mm x 12cm and the deltafill18 3mm x 12cm.No further information was provided by hospital.Section e1: initial reporter phone: (b)(6).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Product complaint#: (b)4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.[complaint conclusion].As reported by an affiliate, during a coil embolization of the major aortopulmonary collateral arteries (mapca) at the collateral circulation coming from the right internal mammary artery, a 4mm x 12cm galaxy g3 coil (gly120412, l12742) was used, but the green system ready light did not illuminate.Therefore, it was replaced with another galaxy g3 coil.Then, the coil of a 3mm x 12cm deltafill 18 coil (dlf180312, l13558) prematurely detached inside the sheath introducer.Therefore, this coil was also replaced with another coil.There was no reported patient injury and the procedure was completed.Additional information received indicated that the devices were prepped as per the instructions for use.There had been no packaging issues.The coil delivery systems were prepped without any difficulty.Pre-deployment electrical testing was performed with the galaxy g3 4mm x 12cm and the deltafill18 3mm x 12cm.No further information was provided by the hospital.A non-sterile unit deltafill18 3mm x 12cm was received inside of a pouch.The hub, re-sheating tool, v notch, introducer appear in normal condition.Heated resistance is heated with no coil.Dpu is damaged (kinked at 2.5 cm from distal tip).Marker band was found at 47 cm from distal end and it was found within specification.The functional teat was not performed due to the coil was already detached and heated resistance was found heated.The root cause could not be determined.A manufacturing record evaluation was performed for the finished device l13558 number, and no non-conformances related to the reported complaint condition were identified.The customer complaint ¿premature detachment-prior to use¿ could not be confirmed due to the condition observed (coil not attached).The root cause of the reported issue could be related to the use of the device during the procedure, however, this cannot be conclusively determined.The rh showed evidence of being heated, indicating that at some point during the procedure, the detachment button was pressed.The exact timing of when it was pressed cannot be determined.It is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.Neither the device history record review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: DELTAFILL18 3MM X 12CM
• Common Device Name: DELTAFILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8717416
• Report Number: 3008114965-2019-01062
• Device Sequence Number: 2022323
• Product Code: KRD
• UDI-Device Identifier: 10886704077190
• UDI-Public: 10886704077190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: DLF180312
• Device Lot Number: L13558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 06/17/2019; 07/16/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/11/2019; 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH INTRODUCER