MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC MICRUSPHERE XL PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number SSR10025320

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

The sterile packing of 20 micrusphere coils was found opened at the sterile seal.It was reported that some of the outer cartons were also damaged.There was no damage to the shipping box.The open seals were found by a sales rep at the distribution center.It was reported that the distributor¿s facility had air conditioning to maintain an ambient temperature, but the air conditioning was turned off when the distributor facility was closed.No damage was found on the actual devices.It was reported that the products were moved frequently between the hospital and distributor (as often as twice per week).Involved products were ssr18092720/c25101, ssr18082520/c22816, ssr10082520/c24108, ssr10051020/ c21852, sph10040020/c16302, ssr10035720/c22177, ssr10030520/c22291, ssr10022520/g15462, ssr18174020/c14414, ssr18133420/c24286, ssr18123020/c25365, ssr18112820/c23425, ssr10072020/c24609, ssr10072020/c22311, ssr10071420/c18273, ssr10062020/c24373, ssr10051420/c14405, ssr10035720/c22858, ssr10025320/c21348, ssr10022520/g15461.

Manufacturer Narrative

The device has been returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.This is 1 of 20 mdrs being submitted for this complaint.

Manufacturer Narrative

Complaint conclusion: the sterile packing of 20 micrusphere coils was found opened at the sterile seal.It was reported that some of the outer cartons were also damaged.There was no damage to the shipping box.The open seals were found by a sales rep at the distribution center.It was reported that the distributor¿s facility had air conditioning to maintain an ambient temperature, but the air conditioning was turned off when the distributor facility was closed.No damage was found on the actual devices.It was reported that the products were moved frequently between the hospital and distributor (as often as twice per week).Involved products were ssr18092720/c25101, ssr18082520/c22816, ssr10082520/c24108, ssr10051020/ c21852, sph10040020/c16302, ssr10035720/c22177, ssr10030520/c22291, ssr10022520/g15462, ssr18174020/c14414, ssr18133420/c24286, ssr18123020/c25365, ssr18112820/c23425, ssr10072020/c24609, ssr10072020/c22311, ssr10071420/c18273, ssr10062020/c24373, ssr10051420/c14405, ssr10035720/c22858, ssr10025320/c21348, ssr10022520/g15461.The original shipping box was not returned.The shipping box from (b)(4) has two large holes in the top and bottom in which the returned products could be seen and mold was found on the box.The external product box has moisture and crush damage.Located on the chevron side of the seal is an opening breaching the sterile seal.Due to the severe damage and large holes in the shipping box sent from (b)(4) containing the complaint products, it cannot be determined how much additional damage occurred during transit.The most likely contributing factor to the external box damage and the sterile breach appears to be related to environmental, handling, and storage issues.All product boxes and pouches are inspected prior to shipment from the (b)(4) manufacturing facility to the distribution warehouse; therefore the circumstances of how and where this damage occurred cannot be determined at this time.However, it was stated that the air conditioning was turned off when the distributor facility was closed in (b)(4).A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The open seal with sterility breach was confirmed through product analysis.Evaluations into the methods used to handle and store items in the (b)(4) market is being pursued with the (b)(4) affiliate and its local distributors.The circumstances which lead to the poor condition of the packages are considered to be isolated to this affiliate/distributor office.This is 1 of 20 mdrs submitted for this complaint, with associated manufacturer report numbers of 2954740-2015-00018, 2954740-2015-00019, 2954740-2015-00020, 2954740-2015-00021, 2954740-2015-00022, 2954740-2015-00023, 2954740-2015-00024, 2954740-2015-00025, 2954740-2015-00026, 2954740-2015-00027, 2954740-2015-00028, 2954740-2015-00029, 2954740-2015-00030, 2954740-2015-00031, 2954740-2015-00032, 2954740-2015-00033, 2954740-2015-00034, 2954740-2015-00035, 2954740-2015-00036, and 2954740-2015-00037.

• Brand Name: MICRUSPHERE XL PLATINUM MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4450109
• MDR Text Key: 5393074
• Report Number: 2954740-2015-00036
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K032872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2018
• Device Catalogue Number: SSR10025320
• Device Lot Number: C21348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1